Conical interspinous apparatus and a method of performing interspinous distraction

ABSTRACT

A conical interspinous apparatus comprising: an insertion portion with a proximal end, a distal end, and conical screw-shaped grooves configured to distract two adjacent spinous processes; a shaft portion, coupled to the distal end of the insertion portion, and having a smaller cross-section than a cross-section at the distal end of the insertion portion, such that the two spinous processes rest on the shaft portion; and a clamp portion being movable and securable along the shaft, and being configured to secure the two spinous processes between the clamp portion and the distal end of the insertion portion.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 12/616,425, filed on Nov. 11, 2009, which is acontinuation-in-part of U.S. patent application Ser. No. 12/343,082,filed on Dec. 23, 2008, which claims priority from U.S. ProvisionalApplication No. 61/092,141, filed on Aug. 27, 2008, both of which areincorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the invention

The present invention relates to the field of interspinous devices, andmore particularly, relates to conical interspinous apparatus insertedbetween two spinous processes of the lumbar spine such that the twospinous processes are separated, the spinal canal opens and the symptomsof spinal stenosis are alleviated. Thus, the conical interspinousapparatus can be used to treat spinal stenosis.

2. Description of the Related Art

Lumbar Spinal Stenosis (LSS) is one of the most common reasons for spinesurgery in older people. Spinal stenosis is a medical condition in whichthe spinal canal narrows and compresses the spinal cord and nerves. Thisis usually due to the natural process of spinal degeneration that occurswith aging. It can also sometimes be caused by spinal disc herniation,osteoporosis or a tumor. Spinal stenosis may affect the cervical orlumbar vertebrae or both. Lumbar spinal stenosis results in lower backpain as well as pain or abnormal sensations in the legs, thighs, feet orbuttocks, or loss of bladder and bowel control.

Laminectomy is a basic part of the surgical treatment of LSS and is themost effective remedy for severe spinal stenosis. Laminectomy can bedone without spinal fusion. However, if the spinal column is unstable,fusion may be required for the laminectomy.

Therefore, a device which can be implanted between two spinous processesof the spine more easily and which involves less invasive proceduresthan present day procedures is needed. Also, a device which can easilybe adapted for both fusion and non-fusion procedures is needed. Such adevice would aid in the treatment for spinal stenosis.

SUMMARY OF THE INVENTION

Exemplary embodiments of the present invention overcome the abovedisadvantages and other disadvantages not described above. Also, thepresent invention is not required to overcome the disadvantagesdescribed above, and an exemplary embodiment of the present inventionmay not overcome any of the problems described above. The presentinvention provides conical interspinous apparatus inserted between twospinous processes of the lumbar spine such that the two spinousprocesses are separated, and a method of performing interspinousdistraction.

According to an exemplary embodiment of the present invention, providedis a conical interspinous apparatus including an insertion portion witha proximal end, a distal end, and conical screw-shaped groovesconfigured to distract two adjacent spinous processes; a shaft portion,coupled to the distal end of the insertion portion, and having a smallercross-section than a cross-section at the distal end of the insertionportion, such that the two spinous processes rest on the shaft portion;and a clamp portion being movable and securable along the shaft, andbeing configured to secure the two spinous processes between the clampportion and the distal end of the insertion portion.

Another exemplary embodiment of the present invention is a method ofperforming interspinous distraction, the method comprising: inserting adistractor having a conical insertion portion and a shaft between twospinous processes of vertebrae, the conical insertion portion configuredsuch that a gradual distraction between the two spinous processesoccurs; inserting an insertion driver while coupled to the distractor,the insertion driver being detachably coupled to a rear portion of thedistractor; implanting the distractor between the two spinous processessuch that the two spinous processes rest on the shaft between a proximalend and a distal end of the shaft; advancing a clamp along the shaftuntil it abuts the spinous process; tightening the clamp; and decouplingthe insertion driver from the distractor and removing the insertiondriver.

Thus, a device which can be implanted between two spinous processes ofthe spine more easily and which involves less invasive procedures isprovided which can be adapted for both fusion and non-fusion procedures.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other aspects of the present invention will become moreapparent from the following description of exemplary embodiments, takenin conjunction with the accompanying drawings of which:

FIG. 1 illustrates an interspinous apparatus according to an exemplaryembodiment of the present invention;

FIG. 2A illustrates a dilator according to an exemplary embodiment ofthe present invention;

FIG. 2B illustrates another view of the dilator shown in FIG. 2A;

FIG. 3 illustrates an interspinous apparatus according to an exemplaryembodiment of the present invention;

FIG. 4 illustrates an interspinous apparatus according to the exemplaryembodiment of the present invention;

FIG. 5 illustrates an interspinous apparatus according to anotherexemplary embodiment of the present invention;

FIG. 6A illustrates an interspinous apparatus having stabilizers in aretracted state according to another exemplary embodiment of the presentinvention;

FIG. 6B illustrates an interspinous apparatus having stabilizers in adeployed state according to the exemplary embodiment of the presentinvention shown in FIG. 6A;

FIG. 7 illustrates a locking mechanism according to an exemplaryembodiment of the present invention;

FIG. 8 illustrates an interspinous apparatus according to anotherexemplary embodiment of the present invention;

FIG. 9 illustrates an interspinous apparatus according to anotherexemplary embodiment of the present invention;

FIG. 10 illustrates an interspinous apparatus according to anotherexemplary embodiment of the present invention;

FIGS. 11A and 11B illustrate an interspinous apparatus according toanother exemplary embodiment of the present invention;

FIGS. 12A and 12B illustrate an interspinous apparatus according toanother exemplary embodiment of the present invention; and

FIGS. 13A-13I illustrate a method of performing interspinous distractionaccording to an exemplary embodiment of the present invention.

FIGS. 14A-14H illustrate an interspinous apparatus according to anotherexemplary embodiment of the present invention.

Throughout the drawings, the same drawing reference numerals will beunderstood to refer to the same elements, features, and structures.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

The matters defined in the description such as a detailed constructionand elements are provided to assist in a comprehensive understanding ofthe embodiment of the invention and are merely exemplary. Accordingly,those of ordinary skill in the art will recognize that various changesand modifications of the embodiment described herein can be made withoutdeparting from the scope and spirit of the invention. Also, descriptionsof well-known functions and constructions are omitted for clarity andconciseness.

The device is composed of a device which has a pointed conical shapewith embedded screw-shaped (i.e., helical) grooves that permit thepassage of the device between the spinous processes of the human spine.The device is designed to be positioned between two spinous processes.It is placed through the interspinous ligament and below thesupra-spinous ligament. The grooved conical surface permits the deviceto be screwed into place in a percutaneous or traditional open surgery.The device is secured between the spinous processes due to a deepercentral engagement groove as well as by mechanisms to be describedwhereby the end(s) of the device are further stabilized. Due to itsposition within the interspinous ligament and below the supra-spinousligament, further stability is obtained.

Furthermore, due to its geometric shape, the device gradually spreadsthe spinous processes apart. By spreading the spinous processes apart,the volume of the spinal canal and vertebral foramen are increasedthereby decompressing the spine in cases of spinal stenosis.

A unique feature of this procedure is that there is no requiredinstrumentation to place the final device into its final position exceptfor a device holding tool (i.e., an insertion driver). Provisionaldilation of the spinous processes can be performed if so desired withsolid dilators also of conical screw or a smooth semi-conical shape. Thedepth and pitch and other parameters of a screw configuration can bemodified to provide faster insertion, more stable insertion, andpositioning of the implant. The central groove may be of a smallercross-section than the insertion portion and broader to accept thespinous process anatomic region in a stable and consistent manner. Thedevice can be either solid or cannulated.

FIG. 1 illustrates a high level drawing of an interspinous apparatus 10according to an exemplary embodiment of the present invention. Theinterspinous apparatus 10 includes a distractor 12, an insertion driver20, and a guide wire 24 having a pointed tip 25. The distractor 12 has aconical shape which is configured to enable passage of the distractor 12between two spinous processes 26 of vertebrae such that a gradualdistraction between the two spinous processes 26 occurs. Each of thedistractor 12 and the insertion driver 20 have a guide channel whichextends through an entire central portion therein configured to acceptthe guide wire 24 therein. The pointed tip 25 of the guide wire 24permits an easier insertion of the guide wire 24 between the two spinousprocesses 26. The guide wire 24 is inserted between the two spinousprocesses 26 in order to guide the insertion of the distractor 12,detachably coupled to the insertion driver 20, between the two spinousprocesses 26.

The distractor 12 has a conical shape which is adapted to enable passageof the distractor 12 between two spinous processes 26 that a gradualdistraction between the two spinous processes 26 occurs. Due to theconical shape of the distractor 12, the distractor 12 has an axis ofdistraction, to be described later, having a constant increasing anglethat provides for constant distraction.

The distractor 12 can be composed of any solid or semi solid materialincluding but not limited to poly-ether-ether-ketone (PEEK), titanium,stainless steel, or bone. In addition, the distractor 12 may be composedof but not limited to hydroxyapatite, bone substitutes, a combination ofhydroxyapatite and bone cement, CORTOSS, or the like. If the distractor12 is composed of any material besides bone, motion is preserved due tothe rolling effect of the cone in extension and flexion. If thedistractor 12 is composed of bone, the device can be used to inducefusion. Thus, the device could also be used to fuse spines depending onwhat material it is made of.

If less motion is so desired, the central engagement groove 14 can bepartially flattened thereby decreasing the rolling effect of the deviceproviding more stability.

If the distractor 12 is composed of bone, the distractor 12 may be usedto treat patients who require fusion with or without decompression ofthe spinal canal and foramen. In patients who do not require a fusion,materials such as PEEK, steel, titanium, or other alloys could beutilized.

FIGS. 2A and 2B illustrate a solid dilator 100 that is used before thedistractor 12 according to an exemplary embodiment of the presentinvention. The dilator 100 includes an insertion portion 113 and acentral engagement groove 114 having a proximal end 115 and a distal end116.

The insertion portion 113 has a conical shape which tapers from theproximal end 115 of the central engagement groove 114 to a tip 117 andis adapted to enable passage of the dilator 100 between the two spinousprocesses 26 such that a gradual distraction between the two spinousprocesses 26 occurs. The insertion portion 113 has embedded screw-shaped(i.e., helical) grooves 118 which permits the device to be screwed intoplace in a percutaneous or traditional open surgery. The grooves 118include sharp edges 118A that are configured to incise through apatient's interspinous ligament (not shown). Because the sharp edges118A are also screw-shaped (i.e., helical), the edges 118A can seriallydilates/spread the interspinous ligament apart. Moreover, the concavegrooves 118 dilator keep the interspinous ligament distracted while thenext edge 118A incises the ligament. The insertion portion 113 an axisof distraction 111 having a constant increasing angle that provides forconstant distraction. The tip 117 of the insertion portion 113 isungrooved to allow for ease of initial insertions, but may be grooved.Furthermore, the tip 119 is hollow, showing a portion of the guidechannel 119 which extends through the entire central portion of thedistractor 112 for accepting the guide wire 124 therein. The tip 119also includes a sharp edge 119A this is configured to cut through thepatient's interspinous ligament.

The central engagement groove 114 is adapted to secure the dilator 100between the two spinous processes 26 such that the two spinous processes26 rest in the central engagement groove 14 between the proximal end 115and the distal end 116.

FIG. 3 illustrates an interspinous apparatus 10 according to anotherexemplary embodiment of the present invention. The distractor isinserted after the dilator 100 is removed and includes an insertionportion 13 and a central engagement groove 14 having a proximal end 15and a distal end 16.

Like the dilator 100, the insertion portion 13 has a conical shape whichtapers from the proximal end 15 of the central engagement groove 14 to atip 17 and is adapted to enable passage of the distractor 12 between thetwo spinous processes 26 such that a gradual distraction between the twospinous processes 26 occurs. The insertion portion 13 has embeddedscrew-shaped (i.e., helical) grooves 18 which permits the device to bescrewed into place in a percutaneous or traditional open surgery. Theinsertion portion 13 an axis of distraction 11 having a constantincreasing angle that provides for constant distraction. The tip 17 ofthe insertion portion 13 is ungrooved to allow for ease of initialinsertions, but may be grooved. Furthermore, the tip 19 is hollow,showing a portion of the guide channel 19 which extends through theentire central portion of the distractor 12 for accepting the guide wire24 therein.

The central engagement groove 14 is adapted to secure the distractor 12between the two spinous processes 26 such that the two spinous processes26 rest in the central engagement groove 14 between the proximal end 15and the distal end 16.

The interspinous apparatus 10 includes the distractor 12 having a rearportion 28 detachably coupled to the insertion driver 20, and the guidewire 24. The insertion portion 13, as shown, has a tip 17 which isgrooved. In contrast to the dilator 100, the distractor 12 includes apair of proximal stabilization wings 30 retracted within a first cavity(not shown) of the distractor 12 and configured to be deployed through apair of proximal slots 32 disposed on opposite sides of the proximal end15 of the central engagement groove 14. The stabilization wings 30 aredeployed after the spinous processes 26 are secured in the centralengagement groove 14 to inhibit the distractor 12 from reversing outfrom between the two spinous processes 26.

The distractor may also include a pair of distal stabilization wings 34retracted within a second cavity (not shown) of the distractor 12 andconfigured to be deployed through a pair of distal slots 36 disposed onopposite sides of the distal end 16 of the central engagement groove 14.The stabilization wings 34 are deployed after the spinous processes 26are secured in the central engagement groove 14 to inhibit thedistractor from being inserted further between the two spinous processes26. Thus, the proximal stabilization wings 30 and the distalstabilization wings 34 stabilize the two spinous processes 26 within thecentral engagement groove 14 and in some embodiments can additionallyclamp onto the spinous processes.

FIG. 4 illustrates an interspinous apparatus 10 having the insertiondriver 20 decoupled from the rear portion 28 of the distractor 12 andthe guide wire 24 removed from the distractor 12. Thus, the distractor12 is shown implanted between the two spinous processes 26 and havingthe proximal stabilization wings 30 and the distal stabilization wings34 deployed from within the distractor 12.

In addition, a circular ring can be slipped over either end of thedevice and tightened thereby providing stability to the implant (notshown).

FIG. 5 illustrates an interspinous apparatus 10 according to anotherexemplary embodiment of the present invention. In particular, thedistractor 12 includes a stabilization base 35 in the alternative to thedistal stabilization wings 34. The stabilization base 35 is coupled tothe distal end 16 of the central engagement groove 14 and which extendsoutward from the distractor 12. The stabilization base 35, much like thedistal stabilization wings 34, is adapted to inhibit the distractor frombeing inserted further between the two spinous processes 26.

FIGS. 6A and 6B illustrate an interspinous apparatus having stabilizers30 and 34 in a retracted state and in a deployed state, respectively,according to another exemplary embodiment of the present invention.

The guide wire 24 is disposed within the guide channel 19, which extendsthrough the entire central portion of the distractor 12 and theinsertion driver 20. Each guide channel 19 of the distractor 12 and theinsertion driver 20 is in alignment with each other.

The distractor 12 includes the pair of proximal stabilization wings 30retracted within a first cavity 40 of the distractor 12. The proximalstabilization wings 30 are configured to be deployed through the pair ofproximal slots 32 disposed on opposite sides of the proximal end 15 ofthe central engagement groove 14. In addition, the distractor 12includes the pair of distal stabilization wings 34 retracted within asecond cavity 42 of the distractor. The distal stabilization wings 34are configured to be deployed through the pair of distal slots 36disposed on opposite sides of the distal end 16 of the centralengagement groove 14.

The distractor 12 includes a deployment bar 44 disposed therein anddetachably coupled to the insertion driver 20. The deployment bar 44 isalso coupled to each stabilization wing of the proximal stabilizationwings 30 and the distal stabilization wings 34. The deployment bar 44 isdisposed within the guide channel 19 of the distractor 12 and isconfigured to be slidably switched between an extended position (asshown in FIG. 6A) and a retracted position (as shown in FIG. 6B).

Thus, when the deployment bar 44 is in the extended position, thedeployment bar 44 maintains the proximal stabilization wings 30 and thedistal stabilization wings 34 in a retracted state. On the other hand,when deployment bar 44 is in the retracted position, the deployment bar44 releases the proximal stabilization wings 30 and the distalstabilization wings 34 to a deployed state. The deployment bar 44 isslidably switched between the extended position and the retractedposition by moving the portion of the insertion driver 20 that isdetachably coupled to the deployment bar 44 in and out of the distractor12.

When the deployment bar 44 is an a retracted position and thestabilization wings 30 and 34 are in the deployed state, thestabilization wings 30 and 34 may be locked into their deployed positionby a lock configured to engage with the deployment bar 44. For example,the portion of the insertion driver 20 that is detachably coupled to thedeployment bar 44 may be rotated, and in turn rotating the deploymentbar 44 within the distractor 12 to a locked position. Once in a lockedstate, the insertion driver 20 can be decoupled from the deployment bar44 and removed from the guide wire 24.

FIG. 7 illustrates a locking mechanism according to an exemplaryembodiment of the present invention. In particular, a rear portion 46(as shown in FIGS. 6A and 6B) of the deployment bar 44 has interlockingmembers 47 which can be rotated clockwise to engage locking slots 48 tolock the deployment bar 44 into place, and thereby, locking thestabilization wings 30 and 34 in the deployed state.

FIG. 8 illustrates an interspinous apparatus according to anotherexemplary embodiment of the present invention. In particular, FIG. 8illustrates an alternative mechanism for deploying the proximalstabilization wings 30 and the distal stabilization wings 34. Thedistractor 12 includes an insertion screw driver 50 disposed within theguide channel of the distractor, coupled to the insertion driver 20 andconfigured to engage a first pair of gears 52 and a second pair of gears54. Each gear 52 and 54 is mechanically coupled to a respectivestabilization wing 30 and 34. Thus, when the insertion driver 20 isturned, the insertion screw driver 50 is turned within the distractor 12and engages with the first pair of gears 52 to deploy the pair ofproximal stabilization wings 30 from the proximal slots 32 and engageswith the second pair of gears 54 to deploy the pair of distalstabilization wings 34 from the distal slots 36.

FIG. 9 illustrates an interspinous apparatus according to anotherexemplary embodiment of the present invention. In particular, FIG. 9illustrates an alternative mechanism for deploying the proximalstabilization wings 30 and the distal stabilization wings 34.

Each stabilization wing of the pair of proximal stabilization wings 30and the pair of distal stabilization wings 34 are coupled to the centralengagement groove 14 by a pressure mechanism 60 such that thestabilization wings 30 and 34 are deployed when the central engagementgroove 14 is pressurized by compression from the two spinous processes26 upon insertion therebetween. The pressure on the central engagementgroove 14 deploys the stabilization wings 30 and 34 from within thedistractor 12.

FIG. 10 illustrates an interspinous apparatus according to anotherexemplary embodiment of the present invention. In particular, FIG. 10illustrates an alternative mechanism for deploying the proximalstabilization wings 30 and the distal stabilization wings 34.

The proximal stabilization wings 30 and distal stabilization wings areballoon O-rings such that the stabilization wings 30 and 34 are deflatedin a retracted state and inflated in a deployed state.

A pump 70 coupled to each of the proximal stabilization wings 30 anddistal stabilization wings 34 is used to inflate the proximalstabilization wings 30 and the distal stabilization wings to a deployedstate 34. The O-rings can be inflated with either a gas or a liquid tostabilize the implant.

FIGS. 11A and 11B illustrate an interspinous apparatus according toanother exemplary embodiment of the present invention. In particular,FIGS. 11A and 11B illustrate an alternative mechanism for deploying theproximal stabilization wings 30. FIGS. 11A and 11B illustrate aninterspinous apparatus having stabilizers 30 in a retracted state and ina deployed state, respectively, according to another exemplaryembodiment of the present invention.

The insertion portion 13 includes a pair of axial rectangular grooves80, each disposed oppositely from each other. Within the pair of axialrectangular grooves 80 is disposed the pair of proximal stabilizationwings 30 or side wings. Each proximal stabilization wing 30 is disposedwithin one of the pair of axial rectangular grooves 80. Furthermore, theproximal stabilization wings 30 are configured to be congruent with ashape of the axial rectangular grooves 80 and with a surface of theinsertion portion 13 in an undeployed state as shown in FIG. 11A. Thus,if the insertion portion 13 has a conical screw shape such that thesurface of the insertion portion has screw-shaped grooves 18, a surfacesof the proximal stabilization wings 30 also have grooves to be congruentthe grooved surface of the insertion portion 13. This enables thedistractor 12 to be screwed into place between the two spinous processes26 when the proximal stabilization wings 30 are undeployed.

The proximal stabilization wings 30 are also configured to be deployedoutward from the axial rectangular grooves 80 as shown in FIG. 11B. Adeployment means 82 deploys the pair of proximal stabilization wings 30from the axial rectangular grooves 80 by pulling the stabilization wings30 towards the proximal end 15 of the central engagement groove 14 suchthat such that the stabilization wings 30 open up from the axialrectangular grooves 80 to a vertical position adjacent to the proximalend 15 of the central engagement groove 14. The stabilization wings 30are coupled to the deployment means 82 by a pair of hinges 84, enablingthe stabilization wings 30 to open to a deployed state.

The distractor 12 may also include the stabilization base 35 similar tothat shown in FIG. 5.

FIGS. 12A and 12B illustrate an interspinous apparatus according toanother exemplary embodiment of the present invention. In particular,FIGS. 12A and 12B illustrate an alternative mechanism for deploying astabilizer.

The distractor 12, and more particularly, the insertion portion 13 maybe composed of differing materials to permit for a collapsing umbrellastabilizing tip to be deployed. The insertion portion 13 is made offlexible material having a first diameter D1 at the proximal end 15 ofthe central engagement groove 14. The insertion portion 13 is configuredto collapse towards the proximal end of the central engagement groovesuch that the insertion portion 13 is compressed into a shape having asecond diameter D2 at the proximal end 15 of the central engagementgroove 14 larger than the first diameter D1 after the distractor 12 isimplanted to inhibit the distractor 12 from reversing out from betweenthe two spinous processes 26.

The distractor 12 includes a wire 90 fed through the guide channel 19and connected to the tip 17 of the insertion portion 13. The tip 17 ofthe insertion portion 13 is adapted to be pulled towards the centralengagement groove 14 upon pulling of the wire 90 to collapse theinsertion portion 13. Thus, the length of portion B collapses, while thelength of portion A remains constant and rigid.

The distractor 12 may also include the stabilization base 35 similar tothat shown in FIG. 5.

Further, it would be understood that the stabilization base 35 asdescribed in FIG. 5 could be implemented in any of the above exemplaryembodiments.

FIGS. 13A-13H illustrate a method of performing interspinous distractionaccording to an exemplary embodiment of the present invention. Themethod includes inserting a guide wire 24 having a pointed tip 25between the two spinous processes 26 (FIG. 13A). The guide wire 24 isconfigured to guide the insertion of the distractor 12 and the insertingof the insertion driver 20 between the two spinous processes 26 whilethe insertion driver 20 is coupled to the distractor 12. The distractor12 and the insertion driver 20 each have a guide channel 19 disposedtherein configured to accept the guide wire 24 therein.

Provisional dilation of the spinous processes 26 is performed withcannulated conical screw or smooth semi conical shape dilators 100 and100, as shown in FIGS. 13B and 13C. During provisional dilation, thefirst dilator 100 is inserted via the guide wire 24 and cuts through theinterspinous ligament (not shown) using the sharp edges 117A, 118A. Thedilator 100 distracts the spinous processes 26 if the dilator 100 comesinto contact with the spinous processes 26. Then, the first dilator 100is removed.

If the first dilator 100 does not contact the spinous processes 26, asecond dilator 101 is inserted via the guide wire 24. The second dilator101 is larger than the first dilator 100 and also cuts through theinterspinous ligament. If necessary, several dilators 100, 101, etc. canbe used until one of the dilators contacts the spinous processes 26. Thedilators can have slightly increasing outer diameters. For example, a 6mm, an 8 mm, a 10 mm, a 12 mm, and a 14 mm dilator can be used.

Contact between the dilator and the spinous processes 26 can be felt dueto the tension provided between the spinous processes 26 by the superspinous ligament (not shown). Once the proper size is determined by thedilator, a distractor of an appropriate size can be selected.

The method further includes inserting the distractor 12 having a conicalinsertion portion 13 and a central engagement groove 14 between the twospinous processes 26 (FIG. 13D). The conical insertion portion 13 isadapted such that a gradual distraction between the two spinousprocesses occurs 26. The insertion drive 20 acts as a device holdingtool for inserting the distractor 12 between the spinous processes 26.Thus, FIG. 13D also illustrates inserting the insertion driver 20 whilecoupled to the distractor 12, the insertion driver 20 being detachablycoupled to a rear portion 28 of the distractor 12.

The method further includes implanting the distractor 12 between the twospinous processes 26 such that the two spinous processes 26 rest in thecentral engagement groove 14 between a proximal end 15 and a distal end16 of the central engagement groove 14 (FIG. 13E).

The method further includes deploying a stabilizer (e.g., stabilizationwings 30 and 34) which is adapted to be deployed from within thedistractor 12 to secure the two spinous processes 26 within the centralengagement groove 14 (FIG. 13F). The stabilizer may also be locked intothe deployed state (FIG. 13F).

The method further includes decoupling the insertion driver 20 from thedistractor 12 (FIGS. 13G and 13H) and removing the insertion driver 20and the guide wire 24 (FIG. 13I).

FIGS. 14A-14H illustrate an interspinous apparatus according to anotherexemplary embodiment of the present invention. In this embodiment, theapparatus can be clamped onto the spinous process after being implanted.

FIG. 14A shows the features of the apparatus including the insertionportion 143 and guide channel 149, as explained above, as well as ashaft 146, which is connected to the insertion portion 143 and passesthrough the clamp 141. In this particular embodiment, clamp 141 is shownin an elliptical shape, however, the clamp 141 could also be circular,rectangular, or any other advantageous shape. Teeth 144 may be presenton the clamp 141 and are configured to create additional frictionbetween the bony mater of the spinous process and the clamp 141. Theteeth 144 can be sharp and shaped accordingly having a conical,pyramidal or other desired shape.

FIG. 14B better illustrates the distal end of the apparatus includingthe distal end of the shaft 146, and instrument mating feature 147,where an insertion driver 20 (shown in FIG. 3) or any other instrumentcan be attached for the purpose of implantation, removal, repositioning,etc. of the implant.

FIGS. 14C-14E specifically show one particular embodiment of theapparatus 140 where the clamp 141 has two parts: a washer 141 a and aretention nut 141 b. In these figures, the apparatus is showndisassembled into its three main parts: washer 141 a, retention nutportion 141 b, and insertion portion 143. As shown in FIG. 14C, theshaft 146 can have a cross-section that is smaller than that of thedistal end of the insertion portion 143. The smaller cross-section ofthe shaft portion is configured to secure the distractor between the twospinous processes such that the two spinous processes rest on the shaftportion. The shaft 146 may be threaded, as shown, stepped, have africtioned surface or smooth.

After the apparatus 140 has been inserted between the spinous processes,it can be clamped to the spinous processes by advancing the retentionnut 141 b, which in this embodiment is in a rotational manner, towardthe washer 141 a and the insertion portion 143. The spinous processbecomes clamped between the distal end of the insertion portion 143 andthe washer 141 a. When adequate compression has been achieved theretention nut 141 b automatically locks to the washer 141 a whenfeatures 160 and 158 mate and prevent rotation of the washer 141 a andnut 141 b. To further secure the clamp 141 a and the retention nut 141 btogether, the retention nut 141 b can be surrounded by one or moreretention lips 150, located on the washer 141 a, configured to have arim to grasp onto a mating rim of the retention nut 141 b.

Washer protrusions 160 and the retention nut protrusions 158 are meantto mate together to prevent rotation after final tightening of theretention nut 141 b with respect to the shaft 146. This is necessary toprevent the retention nut 141 b from unscrewing and allowing theassembly to come apart after implantation. Protrusions 158 and 160 canbe any shape including semi-cylindrical, as shown. The apparatus 140 maycontain a full circle of protrusions 158 and 160 around the washer 141 aand retention nut 141 b openings, or the protrusions 158 and 160strategically placed on only certain portions of the washer 141 a andretention nut 141 b.

Alternate embodiments can contain at least one orientation slot 152which interlocks with at least one orientation key 154 to keep the shaft146, and washer 141 a properly aligned. In other embodiments there maybe a graft cavity 156, which is configured to retain biologicalmaterial, such as a bone graft, to promote bone fusion.

FIGS. 14F-14H illustrate the apparatus 140 as it is inserted between twospinous processes. Initially, as shown in FIG. 14F, the apparatus 140 isin its “open” position where the washer 141 a and retention nut 141 bare farther from the insertion portion 143 than when the apparatus 140is in its “clamped” position as show in FIG. 14H. FIG. 14G shows theapparatus 140 in its final position before the retention nut 141 b istightened and the clamp 141 a is secured to the spinous process.

1. A conical interspinous apparatus comprising: an insertion portion with a proximal end, a distal end, and conical screw-shaped grooves configured to distract two adjacent spinous processes; a shaft portion, coupled to the distal end of the insertion portion, and having a smaller cross-section than a cross-section at the distal end of the insertion portion, such that the two spinous processes rest on the shaft portion; wherein the insertion portion and shaft portion have a guide channel disposed therein configured to accept a guide wire; and a clamp portion being movable and securable along the shaft portion, and being configured to secure the two spinous processes between the clamp portion and the distal end of the insertion portion.
 2. The conical interspinous apparatus of claim 1, further comprising a guide wire having a pointed tip, the guide wire being adapted for insertion between the two spinous processes, the guide wire configured to guide the inserting of the insertion portion and shaft portion between the two spinous processes; and


3. The conical interspinous apparatus of claim 1, further comprising an insertion driver detachably coupled to a distal end of the shaft portion, the insertion driver having a guide channel disposed therein configured to accept a guide wire while the insertion driver is coupled to the shaft portion.
 4. The conical interspinous apparatus of claim 1, wherein the clamp portion is circular, elliptical or rectangular in shape.
 5. The conical interspinous apparatus of claim 1, wherein the clamp portion has teeth configured to create friction between the spinous process and the clamp portion
 6. The conical interspinous apparatus of claim 1, wherein the clamp portion includes a retention nut portion.
 7. The conical interspinous apparatus of claim 6, wherein the clamp portion further includes a washer portion.
 8. The conical interspinous apparatus of claim 7, wherein the retention nut portion and washer portion are configured to lock together.
 9. The conical interspinous apparatus of claim 7, wherein at least one of the washer portion and the retention nut portion further comprises at least one protrusion configured to mate together to prevent rotation after implantation.
 10. The conical interspinous apparatus of claim 7, wherein the washer portion further comprises retention lips configured to secure the retention nut portion to the washer portion.
 11. The conical interspinous apparatus of claim 7, wherein the shaft portion further comprises at least one orientation slot, which mates with at least one orientation key located on the washer portion, the slot configured to keep the shaft portion and washer portion properly aligned.
 12. The conical interspinous apparatus of claim 1 wherein the shaft portion may be threaded, smooth, stepped or have a frictional surface.
 13. The conical interspinous apparatus of claim 1, wherein the shaft portion includes a graft cavity configured to retain graft material within the apparatus.
 14. The conical interspinous apparatus of claim 1, wherein the insertion portion has an axis of distraction having a constant increasing angle that provides for constant distraction.
 15. The conical interspinous apparatus of claim 1, wherein the insertion portion further comprises an ungrooved tip.
 16. The conical interspinous apparatus of claim 1, wherein the distractor is composed of at least one of poly-ether-ether-ketone (PEEK), titanium, stainless steel, bone, hydroxyapatite, bone substitutes, a combination of hydroxyapatite and bone cement, and CORTOSS.
 17. The conical interspinous apparatus of claim 1, wherein the insertion portion includes a stabilizer.
 18. The conical interspinous apparatus of claim 17, further comprising a deployment means configured to deploy the stabilizer.
 19. The conical interspinous apparatus of claim 17, wherein the stabilizer comprises a pair of proximal stabilization wings configured to be deployed from a retracted state to a deployed state.
 20. The conical interspinous apparatus of claim 19, wherein the proximal stabilization wings are configured to be deployed through a pair of slots disposed on opposite sides of the insertion portion. 